Methodological issues with pharmacogenomic biomarkers in relation to clinical development and patient selection - Scientific guideline

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This document highlights key principles that should be considered by stakeholders with focus on use of genomic biomarkers in relation to patient selection and associated issues with trial methodology.

Keywords: Clinical trial designs, enriched design, genomic biomarkers (GBMS), hybrid design, predictive markers, pharmacogenomics, retrospective data analyses

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